Urocross Expander System (Model Numbers ES2018 and ES3025)
FDA 510(k) clearance K253525 · decided 2026-03-12
Clearance details
- K-number
- K253525
- Device name
- Urocross Expander System (Model Numbers ES2018 and ES3025)
- Applicant
- Prodeon Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-13
- Decision date
- 2026-03-12
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- QKA
- Device class
- 2
- Regulation number
- 876.5510
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Urocross Expander System (UES-2018-C1) (K261342) | Prodeon Medical, Inc. | 2026-06-22 |
| iTind System (K210138) | Medi-Tate , Ltd. | 2021-06-25 |
| iTind System (DEN190020) | Medi-Tate , Ltd. | 2020-02-25 |
Recalls involving this device
No recalls on record reference this clearance.